Phase III Trial to Assess the Safety and Efficacy of TK-254RX in Patients With Contusions

NCT06871046 | Completed Phase 3 FDA Drug

• 2 other identifiers: TK-254RX-03022024-513064-26-00
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 5

Brief Summary

This study is an open-label, multi-centric clinical trial to evaluate the safety and efficacy of TK-254RX in patients with contusions. The primary objective of this study is to assess the safety of TK-254RX. Secondly objective is to evaluate the efficacy of contusions and adhesion of TK-254RX.

Conditions

Contusions

Keywords

Blunt trauma; Soft tissue injuries; sports injuries; NSAIDs; topical patch

Outcome Measures

Primary Outcomes (1)

• Recording adverse event and serious adverse event

  Characterization of occurence of adverse events or serious adverse events of TK-254RX

  Day 1 to Day 8

Secondary Outcomes (19)

• 100-mm Visual Analogue Scale (VAS) score on pain-on-movement (POM)

  Day 1 to Day 8

• 100-mm Visual Analogue Scale (VAS) score on pain-at-rest (PAR)

  Day 1 to Day 8

• Sum of Pain Intensity Difference (SPID) on pain-on-movement (POM)

  Day 1 to Day 8

• Sum of Pain Intensity Difference (SPID) on pain-at-rest (PAR)

  Day 1 to Day 8

• Pain Intensity Difference (PID) on pain-on movement (POM)

  Day 1 to Day 8

Study Arms (1)

TK-254RX

EXPERIMENTAL

Esflurbiprofen Topical System 165 mg Esflurbiprofen

Drug: Esflurbiprofen Topical System (EFTS)

Interventions

Esflurbiprofen Topical System (EFTS) DRUG

One EFTS is applied to the injured area over 7 days

TK-254RX

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• acute contusion of the upper or lower limbs
• location of injury such that pain-on-movement is elicited on active standardized movement
• enrollment within 6 hours of the injury
• baseline VAS score for POM of injured extremity \> 50 mm on a 100 mm VAS
• size of injury, as assessed by Investigator, ≥ 25 cm² and ≤ 120 cm²
• adult male or female patients
• age 18 to 64 years (including)
• having given written informed consent
• satisfactory health as determined by the Investigator based on medical history and physical examination

You may not qualify if:

• significant concomitant injury in association with the index soft- tissue injury/contusion; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound
• current skin disorder or shaving hair at application site
• history of excessive sweating/hyperhidrosis inclusive of application site
• intake of long-acting NSAIDs or application of topical medication since the injury
• participation in this clinical study in another center
• drug or alcohol abuse in the opinion of the Investigator
• pregnant and lactating women
• women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
• Surgical sterilization
• Combined (estrogen and progestogen containing) hormonal contraception, e.g., oral, intravaginal, transdermal and progestogen-only hormonal contraception e.g. oral, injectable, implantable as well as intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) each in combination with male condom to increase safety effect (double barrier method)
• Total abstinence throughout the study at the discretion of the Investigator.
• Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the study.
• A woman who is post-menopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child bearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of sterilisation, salpingectomy) or six months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
• known hypersensitivity to Esflurbiprofen, R-flurbiprofen or one of the excipients of the patch
• patients with any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of Esflurbiprofen

Sponsors & Collaborators

• Teikoku Seiyaku Co., Ltd.: lead
• Clinsearch GmbH: collaborator
• CRM Biometrics GmbH: collaborator
• SocraTec R&D GmbH: collaborator
• SocraMetrics GmbH: collaborator
• HWI pharma services GmbH: collaborator

Study Sites (5)

Medical Practice Ebert

Siemensstr, Bonn, 53121, Germany

Location

Medical Practice Prof. Predel

Siemensstr, Bonn, 53121, Germany

Location

Medical Practice Schaale-Maas

Siemensstr, Bonn, 53121, Germany

Location

Medical Practice Pabst

Sportschule Puch, Fürstenfeldbruck, 82556, Germany

Location

Medical Practice Gastl

Römerstraße, Gilching, 82205, Germany

Location

MeSH Terms

Conditions

Contusions; Wounds, Nonpenetrating; Soft Tissue Injuries; Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Kenichi Nishiyama

  Teikoku Seiyaku Co., Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 11, 2025
• Study Start: February 20, 2025
• Primary Completion: September 22, 2025
• Study Completion: October 1, 2025
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)